San Jose, California, United States, October 13, 2026
Vantis Vascular, Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its new 6 French (6F) model of the CrossFAST® Integrated Microcatheter Advanced Delivery System, expanding the company’s portfolio of technologies designed for complex coronary interventions. Announced on October 13, 2026, the clearance introduces a larger-size option intended to accommodate a broader range of interventional devices while retaining the integrated design and deliverability of the existing CrossFAST platform. The new model features a larger internal lumen and a shorter distal tip, allowing physicians to use additional technologies during complex percutaneous coronary intervention (PCI) procedures. These include intravascular ultrasound (IVUS), which helps clinicians visualize blood vessels from within, and intravascular lithotripsy (IVL), which uses sonic pressure waves to modify calcified plaque. The company expects the 6F model to become commercially available in November 2026, alongside its existing 5.5 French model. The regulatory milestone reflects continuing innovation in interventional cardiology and catheter-based medical devices, where improved device compatibility and navigation can be important when treating challenging coronary anatomy.
FDA Clearance Expands CrossFAST Device Options
The FDA cleared the new CrossFAST model under 510(k) number K262817, with the regulatory decision dated September 18, 2026. The 510(k) pathway determines whether a device is substantially equivalent to a legally marketed predicate device for its intended use; it is not the same as FDA premarket approval. The CrossFAST Integrated Microcatheter Advanced Delivery System is intended to be used with guide catheters to access specific regions of the coronary and peripheral vasculature and facilitate placement of interventional devices. The new 6F version expands the existing platform, which has been commercially available in the United States since January 2025. By offering both 5.5F and 6F configurations, Vantis Vascular aims to provide interventional cardiologists with additional flexibility when selecting equipment for different procedural requirements. The larger lumen is designed to accommodate more interventional technologies, while the shorter distal tip supports use in complex PCI procedures. These design changes are intended to broaden the range of cases in which the CrossFAST platform can be used. The clearance represents a regulatory and product-expansion milestone, although it does not by itself establish superior clinical outcomes compared with other delivery systems.
Larger Lumen Supports Advanced Coronary Procedures
A central feature of the new 6F CrossFAST model is its larger internal lumen, which is designed to accommodate technologies such as IVUS and IVL. IVUS provides detailed images of blood vessel interiors and can help physicians assess vessel dimensions, plaque characteristics, and stent placement during coronary interventions. IVL is used in selected cases to modify heavily calcified arterial lesions, helping prepare them for subsequent treatment. Compatibility with these technologies may be valuable in complex PCI procedures, where calcification and challenging vessel anatomy can complicate device delivery. The new model also incorporates a shorter distal tip, another design feature intended to support procedural flexibility. CrossFAST uses DuoPRO™ Interlocking Technology, which couples an inner monorail microcatheter with an outer delivery catheter so that the two components advance together as an integrated unit. This design is intended to help interventional cardiologists navigate difficult anatomy and facilitate the delivery of other devices. According to Vantis Vascular, the expanded platform is designed to retain the integrated approach of the existing system while increasing its compatibility with interventional technologies. Broader device compatibility may help physicians adapt their equipment to procedural needs, but actual performance depends on the anatomy, selected devices, and clinical circumstances.
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Commercial Launch Targets November 2026
Vantis Vascular plans to make the 6F CrossFAST model commercially available in November 2026, adding it to the existing 5.5F option. The company describes itself as a physician-founded medical technology business focused on developing devices for coronary and peripheral vascular interventions. Its product strategy emphasizes technologies intended to improve device delivery and help clinicians manage technically demanding procedures. The introduction of the 6F model follows the earlier commercial launch of CrossFAST in the United States and broadens the available configurations for interventional specialists. Jason Turner, chief executive officer of Vantis Vascular, described the new model as an expansion of the platform designed around physicians’ needs while maintaining its integrated design and deliverability. Interventional cardiologist Jasvindar Singh, MD, of Washington University and Barnes-Jewish Hospital, highlighted the potential importance of accommodating IVUS and a broader range of technologies in complex PCI cases. As the new model enters the market, physician experience, procedural performance, compatibility, and safety will remain important considerations. The FDA clearance strengthens Vantis Vascular’s position in the interventional cardiology device sector and highlights the role of incremental design improvements in expanding catheter-based treatment options.
Source: Vantis Vascular press release
